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Eurofins | Newsflash - May 2018 | Medical Devices

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Friday, May 4, 2018

Europe 

EN ISO 13485- standard updates

 

The following standard update and guidance related to EN ISO 13485 have been recently published by CEN (European Committee for Standardization)
 

Reference Title Date of availability Notes
EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) 28-03-2018 Supersedes
EN ISO 13485:2016/AC:2016
CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation 21-03-2018 Normative reference
EN ISO 13485:2016

 

Switzerland

Draft proposal to adapt to EU legislation

On 27th March, the Swiss Federal Office of Public Health notified to World Trade Organization the Draft Act amending the Federal Law on Medicinal Products and Medical Devices (Law on Therapeutic Products, LPTh)).


The aim of this proposal is to adapt to EU legislation and to improve the safety and quality of medical devices in Switzerland.


Click 
here for getting the Swiss Draft from the European Commission website with reference G/TBT/N/CHE/229